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Background: Primary febrile neutropenia (FN) prophylaxis with ciprofloxacin or granulocyte-colony stimulating factors (G-CSF) is recommended with docetaxel-cyclophosphamide (TC) chemotherapy for early-stage breast cancer (EBC). A pragmatic randomised trial compared the superiority of G-CSF to ciprofloxacin and a cost-utility analysis were conducted., Methods: EBC patients receiving TC chemotherapy were randomised to ciprofloxacin or G-CSF. The primary outcome was a composite of FN and non-FN treatment-related hospitalisation. Secondary outcomes included; rates of FN, non-FN treatment-related hospitalisation, chemotherapy dose reductions/delays/discontinuations. Primary analysis was performed with the intention to treat population. Cost-utility analyses were conducted from the Canadian public payer perspective., Results: 458 eligible patients were randomised: 228 to ciprofloxacin and 230 to G-CSF. For the primary endpoint there was non-statistically significant difference (Risk difference = -6.7%, 95%CI = -13.5%-0.1%, p = 0.061) between ciprofloxacin patients (46,20.2%) and G-CSF (31,13.5%). Patients receiving ciprofloxacin were more likely to experience FN (36/228, 15.8% vs 13/230, 5.7%) than patients receiving G-CSF (p < 0.001). Non-FN treatment-related hospitalisation occurred in 40/228 (17.5%) of ciprofloxacin patients vs 28/230 (12.2%) of G-CSF patients (p = 0.12). There were no differences in other secondary outcomes. G-CSF was associated with an incremental cost-effectiveness ratio of C$1,760,796 per one quality-adjusted life year gained., Conclusion: The primary endpoint of superiority of G-CSF over ciprofloxacin was not demonstrated. While there were reduced FN rates with G-CSF, there were no differences in chemotherapy dose delays/reductions or discontinuations. With the commonly used willingness to pay value of C$50,000/QALY, G-CSF use was not cost-effective compared to ciprofloxacin and deserves scrutiny from the payer perspective., Competing Interests: Declaration of competing interest MC reports personal fees (honoraria) from Pfizer. AAJ reports personal fees (honoraria or travel funds) from Mylan, Teva, Purdue, BMS, BI, Genomic Health, PUMA, Pfizer, Roche, Astra Zeneca, Novartis and Eli Lilly, outside the submitted work. JPH reports institutional research funds from Roche and BMS, outside the submitted work. JM reports personal fees (honorarium) from Pfizer and share ownership in Pacylex Pharmaceutical Inc, SMHeart Card Inc, and illumiSonics, outside the submitted work. TN reports personal fees (honoraria) from ARIAD, Takeda and Boehringer-Ingelheim, outside the submitted work. AA reports personal fees (honorarium for advisory board participation) from Novartis, outside the submitted work. LP reports personal fees (honorarium from advisory board participation) from Serono Oncology, outside the submitted work. NN reports personal fees (honorarium) from Roche, and institutional research funds from Pfizer, outside the submitted work. BH reports consulting fees from Cornerstone Research, outside the submitted work. JFH reports consulting fees from BMS, Pfizer, Eli-Lilly, Novartis and Merck, outside the submitted work. All other authors declare no competing interests., (Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.)